Transplantation of Human Embryonic Stem Cell–Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction
In addition to scalability, human embryonic stem cells (hESCs) have the unique advantage of allowing their directed differentiation toward lineage-specific cells. This study tested the feasibility of leveraging the properties of hESCs to generate clinical-grade cardiovascular progenitor cells and as...
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| Veröffentlicht in: | Journal of the American College of Cardiology 2018-01, Vol.71 (4), p.429-438 |
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| creator | Menasché, Philippe Vanneaux, Valérie Hagège, Albert Bel, Alain Cholley, Bernard Parouchev, Alexandre Cacciapuoti, Isabelle Al-Daccak, Reem Benhamouda, Nadine Blons, Hélène Agbulut, Onnik Tosca, Lucie Trouvin, Jean-Hugues Fabreguettes, Jean-Roch Bellamy, Valérie Charron, Dominique Tartour, Eric Tachdjian, Gérard Desnos, Michel Larghero, Jérôme |
| description | In addition to scalability, human embryonic stem cells (hESCs) have the unique advantage of allowing their directed differentiation toward lineage-specific cells.
This study tested the feasibility of leveraging the properties of hESCs to generate clinical-grade cardiovascular progenitor cells and assessed their safety in patients with severe ischemic left ventricular dysfunction.
Six patients (median age 66.5 years [interquartile range (IQR): 60.5 to 74.7 years]; median left ventricular ejection fraction 26% [IQR: 22% to 32%]) received a median dose of 8.2 million (IQR: 5 to 10 million) hESC-derived cardiovascular progenitors embedded in a fibrin patch that was epicardially delivered during a coronary artery bypass procedure. The primary endpoint was safety at 1 year and focused on: 1) cardiac or off-target tumor, assessed by imaging (computed tomography and fluorine-18 fluorodeoxyglucose positron emission tomography scans); 2) arrhythmias, detected by serial interrogations of the cardioverter-defibrillators implanted in all patients; and 3) alloimmunization, assessed by the presence of donor-specific antibodies. Patients were followed up for a median of 18 months.
The protocol generated a highly purified (median 97.5% [IQR: 95.5% to 98.7%]) population of cardiovascular progenitors. One patient died early post-operatively from treatment-unrelated comorbidities. All others had uneventful recoveries. No tumor was detected during follow-up, and none of the patients presented with arrhythmias. Three patients developed clinically silent alloimmunization. All patients were symptomatically improved with an increased systolic motion of the cell-treated segments. One patient died of heart failure after 22 months.
This trial demonstrates the technical feasibility of producing clinical-grade hESC-derived cardiovascular progenitors and supports their short- and medium-term safety, thereby setting the grounds for adequately powered efficacy studies. (Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure [ESCORT]; NCT02057900)
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| doi_str_mv | 10.1016/j.jacc.2017.11.047 |
| format | Article |
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This study tested the feasibility of leveraging the properties of hESCs to generate clinical-grade cardiovascular progenitor cells and assessed their safety in patients with severe ischemic left ventricular dysfunction.
Six patients (median age 66.5 years [interquartile range (IQR): 60.5 to 74.7 years]; median left ventricular ejection fraction 26% [IQR: 22% to 32%]) received a median dose of 8.2 million (IQR: 5 to 10 million) hESC-derived cardiovascular progenitors embedded in a fibrin patch that was epicardially delivered during a coronary artery bypass procedure. The primary endpoint was safety at 1 year and focused on: 1) cardiac or off-target tumor, assessed by imaging (computed tomography and fluorine-18 fluorodeoxyglucose positron emission tomography scans); 2) arrhythmias, detected by serial interrogations of the cardioverter-defibrillators implanted in all patients; and 3) alloimmunization, assessed by the presence of donor-specific antibodies. Patients were followed up for a median of 18 months.
The protocol generated a highly purified (median 97.5% [IQR: 95.5% to 98.7%]) population of cardiovascular progenitors. One patient died early post-operatively from treatment-unrelated comorbidities. All others had uneventful recoveries. No tumor was detected during follow-up, and none of the patients presented with arrhythmias. Three patients developed clinically silent alloimmunization. All patients were symptomatically improved with an increased systolic motion of the cell-treated segments. One patient died of heart failure after 22 months.
This trial demonstrates the technical feasibility of producing clinical-grade hESC-derived cardiovascular progenitors and supports their short- and medium-term safety, thereby setting the grounds for adequately powered efficacy studies. (Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure [ESCORT]; NCT02057900)
[Display omitted]</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2017.11.047</identifier><identifier>PMID: 29389360</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Antibodies ; Antigens ; Bypass ; Cardiology ; Cardiomyocytes ; cardiovascular progenitor cells ; Computed tomography ; Coronary artery ; Coronary vessels ; Defibrillators ; Embryo cells ; embryonic stem cells ; Embryos ; Emission analysis ; Feasibility studies ; Fibrin ; Fluorine ; Heart ; Heart attacks ; Heart diseases ; Heart failure ; Heart surgery ; Ischemia ; Isoimmunization ; Patients ; Positron emission ; Positron emission tomography ; Progenitor cells ; Regulatory approval ; Safety ; Stem cells ; Tissue engineering ; Tomography ; Transcription factors ; Transplantation ; Variance analysis ; Ventricle</subject><ispartof>Journal of the American College of Cardiology, 2018-01, Vol.71 (4), p.429-438</ispartof><rights>2018 American College of Cardiology Foundation</rights><rights>Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Jan 30, 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c494t-e9f242aa233f6235d4110cb15b2f456f84bb72c7327739a055b3a70e4a1de4e23</citedby><cites>FETCH-LOGICAL-c494t-e9f242aa233f6235d4110cb15b2f456f84bb72c7327739a055b3a70e4a1de4e23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0735109717417281$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29389360$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Menasché, Philippe</creatorcontrib><creatorcontrib>Vanneaux, Valérie</creatorcontrib><creatorcontrib>Hagège, Albert</creatorcontrib><creatorcontrib>Bel, Alain</creatorcontrib><creatorcontrib>Cholley, Bernard</creatorcontrib><creatorcontrib>Parouchev, Alexandre</creatorcontrib><creatorcontrib>Cacciapuoti, Isabelle</creatorcontrib><creatorcontrib>Al-Daccak, Reem</creatorcontrib><creatorcontrib>Benhamouda, Nadine</creatorcontrib><creatorcontrib>Blons, Hélène</creatorcontrib><creatorcontrib>Agbulut, Onnik</creatorcontrib><creatorcontrib>Tosca, Lucie</creatorcontrib><creatorcontrib>Trouvin, Jean-Hugues</creatorcontrib><creatorcontrib>Fabreguettes, Jean-Roch</creatorcontrib><creatorcontrib>Bellamy, Valérie</creatorcontrib><creatorcontrib>Charron, Dominique</creatorcontrib><creatorcontrib>Tartour, Eric</creatorcontrib><creatorcontrib>Tachdjian, Gérard</creatorcontrib><creatorcontrib>Desnos, Michel</creatorcontrib><creatorcontrib>Larghero, Jérôme</creatorcontrib><title>Transplantation of Human Embryonic Stem Cell–Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>In addition to scalability, human embryonic stem cells (hESCs) have the unique advantage of allowing their directed differentiation toward lineage-specific cells.
This study tested the feasibility of leveraging the properties of hESCs to generate clinical-grade cardiovascular progenitor cells and assessed their safety in patients with severe ischemic left ventricular dysfunction.
Six patients (median age 66.5 years [interquartile range (IQR): 60.5 to 74.7 years]; median left ventricular ejection fraction 26% [IQR: 22% to 32%]) received a median dose of 8.2 million (IQR: 5 to 10 million) hESC-derived cardiovascular progenitors embedded in a fibrin patch that was epicardially delivered during a coronary artery bypass procedure. The primary endpoint was safety at 1 year and focused on: 1) cardiac or off-target tumor, assessed by imaging (computed tomography and fluorine-18 fluorodeoxyglucose positron emission tomography scans); 2) arrhythmias, detected by serial interrogations of the cardioverter-defibrillators implanted in all patients; and 3) alloimmunization, assessed by the presence of donor-specific antibodies. Patients were followed up for a median of 18 months.
The protocol generated a highly purified (median 97.5% [IQR: 95.5% to 98.7%]) population of cardiovascular progenitors. One patient died early post-operatively from treatment-unrelated comorbidities. All others had uneventful recoveries. No tumor was detected during follow-up, and none of the patients presented with arrhythmias. Three patients developed clinically silent alloimmunization. All patients were symptomatically improved with an increased systolic motion of the cell-treated segments. One patient died of heart failure after 22 months.
This trial demonstrates the technical feasibility of producing clinical-grade hESC-derived cardiovascular progenitors and supports their short- and medium-term safety, thereby setting the grounds for adequately powered efficacy studies. (Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure [ESCORT]; NCT02057900)
[Display omitted]</description><subject>Antibodies</subject><subject>Antigens</subject><subject>Bypass</subject><subject>Cardiology</subject><subject>Cardiomyocytes</subject><subject>cardiovascular progenitor cells</subject><subject>Computed tomography</subject><subject>Coronary artery</subject><subject>Coronary vessels</subject><subject>Defibrillators</subject><subject>Embryo cells</subject><subject>embryonic stem cells</subject><subject>Embryos</subject><subject>Emission analysis</subject><subject>Feasibility studies</subject><subject>Fibrin</subject><subject>Fluorine</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Heart diseases</subject><subject>Heart failure</subject><subject>Heart surgery</subject><subject>Ischemia</subject><subject>Isoimmunization</subject><subject>Patients</subject><subject>Positron emission</subject><subject>Positron emission tomography</subject><subject>Progenitor cells</subject><subject>Regulatory approval</subject><subject>Safety</subject><subject>Stem cells</subject><subject>Tissue engineering</subject><subject>Tomography</subject><subject>Transcription factors</subject><subject>Transplantation</subject><subject>Variance analysis</subject><subject>Ventricle</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp9kU9u1DAUhy0EotPCBVigSGzYJPhvHEts0LSllUYCqYWt5Tgv4CixBzsZaXZsOAEXmLPMUTgJiaawYMHKm-_3vef3Q-gFwQXBpHzTFZ2xtqCYyIKQAnP5CK2IEFXOhJKP0QpLJnKClTxD5yl1GOOyIuopOqOKVYqVeIV-3Efj07Y3fjSjCz4LbXYzDcZnV0Md98E7m92NMBwPa-j7X99_XkJ0O2iytYmNCzuT7NSbmH2M4Qt4N4aYsjbE7A52EOF4uE32KwyzZAPteDx8Bj9Gd4pc7lM7ebtMfYaetKZP8PzhvUCfrq_u1zf55sP72_W7TW654mMOqqWcGkMZa0vKRMMJwbYmoqYtF2Vb8bqW1EpGpWTKYCFqZiQGbkgDHCi7QK9P3m0M3yZIox5csvPHjIcwJU2UYkphRfiMvvoH7cIU_bydphgTQUnFFiE9UTaGlCK0ehvdYOJeE6yXknSnl5L0UpImRM8lzaGXD-qpHqD5G_nTygy8PQEw32LnIOpkHXgLjYtgR90E9z__byVyp70</recordid><startdate>20180130</startdate><enddate>20180130</enddate><creator>Menasché, Philippe</creator><creator>Vanneaux, Valérie</creator><creator>Hagège, Albert</creator><creator>Bel, Alain</creator><creator>Cholley, Bernard</creator><creator>Parouchev, Alexandre</creator><creator>Cacciapuoti, Isabelle</creator><creator>Al-Daccak, Reem</creator><creator>Benhamouda, Nadine</creator><creator>Blons, Hélène</creator><creator>Agbulut, Onnik</creator><creator>Tosca, Lucie</creator><creator>Trouvin, Jean-Hugues</creator><creator>Fabreguettes, Jean-Roch</creator><creator>Bellamy, Valérie</creator><creator>Charron, Dominique</creator><creator>Tartour, Eric</creator><creator>Tachdjian, Gérard</creator><creator>Desnos, Michel</creator><creator>Larghero, Jérôme</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20180130</creationdate><title>Transplantation of Human Embryonic Stem Cell–Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction</title><author>Menasché, Philippe ; 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This study tested the feasibility of leveraging the properties of hESCs to generate clinical-grade cardiovascular progenitor cells and assessed their safety in patients with severe ischemic left ventricular dysfunction.
Six patients (median age 66.5 years [interquartile range (IQR): 60.5 to 74.7 years]; median left ventricular ejection fraction 26% [IQR: 22% to 32%]) received a median dose of 8.2 million (IQR: 5 to 10 million) hESC-derived cardiovascular progenitors embedded in a fibrin patch that was epicardially delivered during a coronary artery bypass procedure. The primary endpoint was safety at 1 year and focused on: 1) cardiac or off-target tumor, assessed by imaging (computed tomography and fluorine-18 fluorodeoxyglucose positron emission tomography scans); 2) arrhythmias, detected by serial interrogations of the cardioverter-defibrillators implanted in all patients; and 3) alloimmunization, assessed by the presence of donor-specific antibodies. Patients were followed up for a median of 18 months.
The protocol generated a highly purified (median 97.5% [IQR: 95.5% to 98.7%]) population of cardiovascular progenitors. One patient died early post-operatively from treatment-unrelated comorbidities. All others had uneventful recoveries. No tumor was detected during follow-up, and none of the patients presented with arrhythmias. Three patients developed clinically silent alloimmunization. All patients were symptomatically improved with an increased systolic motion of the cell-treated segments. One patient died of heart failure after 22 months.
This trial demonstrates the technical feasibility of producing clinical-grade hESC-derived cardiovascular progenitors and supports their short- and medium-term safety, thereby setting the grounds for adequately powered efficacy studies. (Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure [ESCORT]; NCT02057900)
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| ispartof | Journal of the American College of Cardiology, 2018-01, Vol.71 (4), p.429-438 |
| issn | 0735-1097 1558-3597 |
| language | eng |
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| source | Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Antibodies Antigens Bypass Cardiology Cardiomyocytes cardiovascular progenitor cells Computed tomography Coronary artery Coronary vessels Defibrillators Embryo cells embryonic stem cells Embryos Emission analysis Feasibility studies Fibrin Fluorine Heart Heart attacks Heart diseases Heart failure Heart surgery Ischemia Isoimmunization Patients Positron emission Positron emission tomography Progenitor cells Regulatory approval Safety Stem cells Tissue engineering Tomography Transcription factors Transplantation Variance analysis Ventricle |
| title | Transplantation of Human Embryonic Stem Cell–Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction |
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